International Law

Legislation to Ban ?Pay-to-Delay? Drug Agreements Introduced in Congress

This posting was written by Darius Sturmer, Editor of CCH Trade Regulation Reporter.

A bill to prohibit brand name drug manufacturers from compensating generic drug makers to delay the entry of a generic drug into the market was introduced in the House of Representatives by Rep. Bobby Rush (D-Illinois) on March 25.

The legislation specifically addresses, and seeks to ban, provisions in settlements of patent infringement litigation between pharmaceutical companies that involve "reverse payments"?payouts by the brand name drug maker to the generic maker in return for an agreement by the generic to keep its drug off the market for some specified amount of time.

Dubbed the "Protecting Consumer Access to Generic Drugs Act of 2009," the measure (H.R. 1706) would have an effect similar to a proposal introduced in the Senate by Herb Kohl (D-Wisconsin) on February 3. That bill (S. 369), the "Preserve Access to Affordable Generics Act," remains under consideration by the Senate Judiciary Committee.

While aiming to accomplish similar goals, the bills would address the matter through different statutes. The House bill would declare a ?pay-to-delay? agreement an unfair and deceptive act prohibited by the FTC Act, and would grant the FTC the authority to enforce the legislation. The Senate bill would instead amend the Clayton Act, calling the conduct "Unlawful Interference with Generic Marketing."

Another difference between the bills concerns their definitions of what constitutes an applicable "agreement." The House bill refers solely to those constituting an agreement under the FTC Act, while the Senate bill would ban those that are considered agreements by the Sherman Act as well. Both would allow the FTC to create exceptions through its rulemaking process.

Text of H. R. 1706 appears here. Text of S. 369 appears here. Further information about both bills is available at the Library of Congress ?Thomas? website.

Full post as published by Trade Regulation Talk on April 03, 2009 (boomark / email).